Reference Number: JO-2107-471658
Quality Systems Associate
Rate: Negotiable
Job Type: Permanent
Location: Hertfordshire

We are looking for a Quality System Associate on behalf of our client based in Hertfordshire

The ideal candidate would have experience in:

  • Change Controls
  • Qualification and Validation documentation
  • Knowledge of control of Regulatory Information

Details of responsibilities:

  • To support the Product Quality Review process for company.
  • To support the process of generation of Quality Agreements.
  • To support the process for approving suppliers and the maintenance of the Approved Suppliers List.
  • To support the maintenance of a list of Parallel Importers/Distributors of Eisai products as compiled from notifications and samples received by CompnayRegulatory Affairs.
  • To support the generation of the Quality Management Systems Indicator reports.
  • To support the ongoing operation, maintenance, and implementation of improvements to TrackWise processes and systems to meet companyneeds.
  • To supportTraining Management System.
  • To maintain copies of Corporate Policies, Guideline, Standards and Procedures.
  • To write and review all SOPs associated with the Electronic TrackWise QMS
  • To support the company SOP System.
  • To support the internal and external audit process and audit schedules
  • To participate in Audits
  • To support Quality Systems training ofstaff, as required.
  • To coordinate and support GMP Training
  • To support the Deviations System
  • To support theRisk Management System
  • To provide day to day support to other members of the Quality Systems team, as appropriate.
  • Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working
  • To perform any appropriate duties at the request of the Quality Systems Manager.
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